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More Options Available With a Quadripolar LV Lead pRovidE In-clinic Solutions to CRT Challenges (MORE-CRT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01510652
First received: November 30, 2011
Last updated: October 22, 2015
Last verified: October 2015
  Purpose
This investigation is designed with the hypothesis that using a quadripolar left ventricular lead results in less interventions when dealing with high pacing thresholds and Phrenic Nerve Stimulation (PNS), both at implant and during follow-up, compared to standard bipolar left ventricular leads.

Condition Intervention
Postoperative Cardiac Complication Heart Failure, Left Ventricular Cardiac Dysfunction Inappropriate Phrenic Nerve Stimulation Perioperative/Postoperative Complications Procedure: BiP Group Device: Quad Group

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: More Options Available With a Quadripolar Left Ventricular (LV) Lead pRovidE In-clinic Solutions to Cardiac Resynchronization Therapy (CRT) Challenges

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Lead Performance [ Time Frame: 6 months ]

    Percentage of patients with freedom from event (intra- and post-operative). Intra-operative events were defined as: need to use more than 1 left ventricular lead, need to change lead implant position, use of any device to actively fixate the lead, unsuccessful implant, due to phrenic nerve stimulation, high pacing threshold or lead instability.

    Post-operative events were defined as any left ventricular lead related serious adverse device effect and CRT switched off.



Secondary Outcome Measures:
  • Percentage of Cardiac Resynchronization Therapy Responders [ Time Frame: Baseline and 6 months ]
    Percentage of Cardiac Resynchronization Therapy (CRT) responders measured by a decrease of at least 10% of Left Ventricle End-Systolic Volume (LVESV)

  • Implant Duration [ Time Frame: Total duration of the implant procedure reported at the end of the procedure ]
    This measure reports the length (in time) of the implantation procedure. The measurement start at skin incision and stop at skin suture (so called skin-to-skin time) The total implant procedure duration time will be compared between the control and the treatment group.


Enrollment: 1078
Study Start Date: November 2011
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Quad Group
Patients in the Quad group will be implanted with St. Jude Medical (SJM) quadripolar Left Ventricular (LV) lead Quartet
Device: Quad Group
Implantation of quadripolar Left ventricular (LV) lead Quartet
Active Comparator: BiP Group
Patients in the BiP Group will be implanted with a standard (regulatory approved and commercially available) bipolar left ventricular lead from other companies (non St. Jude Medical leads)
Procedure: BiP Group
Implantation of standard Left Ventricular (LV) lead

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients are indicated for Cardiac Resynchronization Therapy with Defibrillation backup device (CRT-D) implantation, as per current international certified guidelines
  • Patients age is 18 years or greater
  • Patients must indicate their understanding of the study and willingness to participate by signing the appropriate informed consent form
  • Patients must be willing and able to comply with all study requirements

Exclusion Criteria:

  • Patients with a life expectancy <12 months.
  • Patients who are or may potentially be pregnant.
  • Patient has suffered any of the following in the 4 weeks prior to enrolment:

    • Myocardial Infarction (MI)
    • Coronary Artery Bypass Graft (CABG)
    • Unstable Angina Pectoris
  • Patient has primary valvular disease which has not been corrected
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01510652

  Show 64 Study Locations
Sponsors and Collaborators
St. Jude Medical
Investigators
Principal Investigator: Giuseppe Boriani, Pro. Policlinico Universitario S. Orsola e Malpighi, Bologna, Italy
  More Information

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01510652     History of Changes
Other Study ID Numbers: CR-11-006-HF-ID
Study First Received: November 30, 2011
Results First Received: August 14, 2015
Last Updated: October 22, 2015

Keywords provided by St. Jude Medical:
Cardiac Resynchronization therapy,
Heart Failure,
Left Ventricular Lead,
Quadripolar Left ventricular Lead,
Phrenic Nerve Stimulation,
Intra and post operative related complications

Additional relevant MeSH terms:
Heart Failure
Postoperative Complications
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 21, 2017